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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01290809
Other study ID # 093074
Secondary ID
Status Completed
Phase N/A
First received February 1, 2011
Last updated October 13, 2015
Start date January 2011
Est. completion date October 2015

Study information

Verified date October 2015
Source Maastricht Radiation Oncology
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial Summary

Stage III non-small cell lung cancer (NSCLC) patients constitute a significant proportion of the lung cancer population. The prognosis of these patients has improved over the years due the introduction of combined modality treatment, including high-dose chemo-radiotherapy. The brain, however, remains one of the major sites of failure. Patients with brain metastasis suffer from a variety of neurological, cognitive and emotional difficulties that are known to adversely affect the health-related quality of life. Prophylactic Cranial Irradiation (PCI) can prevent or delay the development of brain metastasis, and as such can improve neurological disease-free survival and consequently health-related quality of life. But survival is short, and toxicities are real, as PCI in itself can also induce adverse effects. The cognitive adverse effects of PCI are not sufficiently illuminated and documented, due to the lack of formal and systematic evaluation in patient populations expected to have short survival. Also, recent attempts to reduce cognitive side effects of PCI by the application of hippocampal-avoidance PCI in order to prevent memory deficits have not been fully evaluated yet.

Before PCI can be offered routinely to stage III NSCLC patients in daily practice, the costs and benefits of this therapy should be investigated properly, to allow for well-informed treatment choices.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date October 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- UICC stage III A or III B (without malignant pleural or pericardial effusion) non-small cell lung cancer

- Whole body PDG-PET scan before the start of therapy available: no distant metastasis.

- CT or preferably MRI of the brain before the start of radical therapy available; no brain metastasis.

- Platinum-based chemotherapy is mandatory.

- Radical local therapy: concurrent or sequential chemotherapy and radiotherapy with or without surgery.

- Radiotherapy dose without surgery to at least biological equivalent of 60 Gy.

- No prior cranial irradiation.sufficient proficiency in Dutch language

- sufficient proficiency in Dutch language

- MRI (and not CT scan) pre-PCI

Exclusion Criteria:

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Academic Medical Center Amsterdam
Netherlands NKI Amsterdam
Netherlands VU University Medical Center Amsterdam
Netherlands University Medical Center Groningen Groningen

Sponsors (6)

Lead Sponsor Collaborator
Maastricht Radiation Oncology Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Maastricht University Medical Center, The Netherlands Cancer Institute, University Medical Center Groningen, VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary cognitive sequelae The proposed study will investigate the cognitive sequelae of PCI in NSCLC patients in the context of a phase III randomized trial (Nederlandse vereniging van artsen voor longziekten en tuberculose: NVALT-11) on the efficacy of PCI in decreasing the proportion of NSCLC patients developing brain metastasis, and the impact of PCI on neurological symptoms and health-related quality of life. 36 months No
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